The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization.
| Device ID | K211544 |
| 510k Number | K211544 |
| Device Name: | Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Contact | Chiara Cunico |
| Correspondent | Chiara Cunico Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-19 |
| Decision Date | 2021-11-03 |